Project Lung Cancer Screening in Southern Denmark

NCT ID: NCT06537804

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2026-12-31

Brief Summary

One thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. The participants will be identified through an initial questionnaire survey concerning smoking history and general health. Project participants are offered a low-dose CT (LDCT) scan annually for three consecutive years. In relation to the first scan, a lung function test will also be performed. The screening process will be evaluated for possible national implementation of a lung cancer screening program in Denmark.

Detailed Description

This pilot study is a prospective interventional feasibility study. The primary goal is to evaluate the impact on healthcare organization, administration of resources and costs, and thereby assessing the feasibility of implementing systematic screening for lung cancer among people at high risk in Denmark (current or former heavy smokers). The pilot study will be performed on Funen in the Region of Southern Denmark and will run over three years (2024-2026). One thousand randomly selected participants aged 60-74 years old, who meet the screening criteria, will receive annual LDCT scans for three consecutive years.

Data will be collected continuously throughout the study period. The analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. Furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). The analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. Finally, the radiologists' assessments of the project's LDCT scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention

Low-dose CT scans are performed once a year from 2024 to 2026 to screen for lung cancer including a lung function test the first year of attendance (2024).

Group Type: OTHER

Screening by low-dose CT scan

Intervention Type: RADIATION

Screening for lung cancer by low-dose CT scan

Control

Citizens from the cohort who are randomized to no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Screening by low-dose CT scan

Screening for lung cancer by low-dose CT scan

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Heavy smokers (≥ 30 pack years) or citizens with a PLCOm2012 calculated 6-year risk of lung cancer > 2%.
• Age: 60-74 years old
• Residence on Funen and surrounding islands

Exclusion Criteria

• Cancer treatment or follow-up (except non melanoma skin cancer and similar low malignant cancers) within the past 12 months
• CT scan performed within the past 12 months

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Stenger, Consultant

Role: STUDY_DIRECTOR

Odense University Hospital

Locations

Odense University Hospital

Odense, Region Syddanmark, Denmark

Department of Radiology, Svendborg Hospital

Svendborg, Region Syddanmark, Denmark

Countries

Denmark

Other Identifiers

S-20240033

Identifier Type: -

Identifier Source: org_study_id